Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Agamatrix, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
115 daysmedian FDA review time
370 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161834 | One Drop Blood Glucose Monitoring System | Agamatrix, Inc. | 2016-11-30 | 148 | 0 |
| K152365 | AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System | Agamatrix, Inc. | 2016-04-21 | 244 | 0 |
| K132821 | AGAMATRIX HEALTH MANAGER | Agamatrix, Inc. | 2013-11-20 | 72 | 0 |
| K130535 | IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MA | Agamatrix, Inc. | 2013-04-17 | 47 | 0 |
| K103544 | IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MA | Agamatrix, Inc. | 2011-12-07 | 370 | 0 |
| K083265 | JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03 | Agamatrix, Inc. | 2009-02-03 | 90 | 0 |
| K052762 | LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067 | Agamatrix, Inc. | 2006-01-23 | 115 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda